BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PULSAR 2

    MDR report key: 2815592 · Received November 1, 2012

    Report

    Report Number
    1226420-2012-00052
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 5, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, METHOD, RESULTS AND CONCLUSION: PRODUCT SCHEDULED FOR RETURN BUT NOT RECEIVED BY MANUFACTURER FOR INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). EVALUATION PROCESS: UNIT RECEIVED IN FAIR CONDITION AND INTERNAL VISUAL INSPECTION REVEALED NO LOOSE OR BROKEN COMPONENTS. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ERROR LOG: 12 E3 (PATIENT RETURN ELECTRODE HAS POOR CONNECTION) THIS IS A NORMAL USE ERROR. TO ENSURE CUT AND COAG ENERGY DELIVERY WAS NOT OUT OF TOLERANCE/CALIBRATION STEPS 5.6 AND 5.12 OF FINAL TEST (TP-0050) WERE PERFORMED AND THE POWER MEASUREMENTS WERE WITHIN TOLERANCE AND THE COMPLAINT COULD NOT BE CONFIRMED. ROOT CAUSE: THE OUTPUT POWER WAS TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE COMPLAINT OF OVER-POWERED OUTPUT ENERGY COULD NOT BE CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SURGEONS STATE THAT ARCING IS OCCURRING WHILE DISSECTING IN COAG MODE AND THAT THE HAND PIECE SEEMS HOTTER THAN THE NORM CAUSING MORE TISSUE TO BE DAMAGED.

    Description of Event or Problem · 1

    SURGEONS STATE THAT ARCING IS OCCURRING WHILE DISSECTING IN COAG MODE AND THAT THE HAND PIECE SEEMS HOTTER THAN THE NORM CAUSING MORE TISSUE TO BE DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK PULSAR 2 GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1